Small Business Exemptions:
Businesses/products that fulfill the criteria below may be exempt from the requirements for Nutritional Labeling described in Subpart A 101.9
Exemption Possibility #1:
A business who makes sales to a consumer (can be a retailer) who:
- Conducts no more than $500,000 in annual gross sales ofallproductsOR
- Conducts no more than $50,000 in annual gross sales offoodproducts.
The food products exempt from labeling must not make any nutrition claims in the product or advertisem*nt of it.
Exemption Possibility #2:
Low Volume Exemption: A business with fewer than 100 full time employees and fewer than 100,000 units sold in the US (for the preceding 12 months) may be exempt from certain labeling requirements.
The exempt food labels or product advertising may not provide any nutrition information or make a nutrient content claim or health claim.
Source 101.9 (j)Labeling Exemptions
How to Register a Small Business Labeling Exemption:
If the exempt business is not an importer and sells fewer than 10,000 units annually, there is no requirement for registering the exemption.
If the business does not meet the above criteria, then you must file for the exemption each year. You can do thisonline or by submitting this form by mail/fax
Foods that are Exempt From Labeling Requirements:
The following foods are exempt from labeling requirements. There is no registration filing required associated with the food-based exemptions below.
Raw fruits
See AlsoWHMIS - GeneralVegetables
Fish
Dietary Supplements (they are regulated under §101.36)
Certain egg cartons
Infant Formula and foods for children up to 4 yrs of age (modified requirements apply)
Foods that contain insignificant amounts of all nutrients required to be in a nutrition panel (i.e. coffee beans, tea leaves, spices, flavor extracts, food colors,)
Packaged single-ingredient meat products that are FDA-regulated (i.e. deer, bison, rabbit, quail, wild turkey, ostrich)
Foods in small packages that have a total surface area of <12 sq inches
Foods served or delivered for immediate consumption
Food that is served in bulk containers at a retail establishment. The retail establishment must include the ingredients listing on a card or sign, if not on the bulk container itself.
Foods that are prepared inside a retail establishment and only sold in that establishment (i.e. foods processed and sold onsite by independent delis, bakeries, or salad bars)
Ingredients that are added to a food for an effect in processing but are present in the finished product at insignificant levels.
Some products that are being transported to another facility where they will be processed, packed, or labeled.
As someone deeply entrenched in regulatory compliance and small business practices, I'm well-versed in the intricate details of labeling exemptions, especially those concerning nutritional information. The FDA's Subpart A 101.9 outlines exemptions for small businesses based on various criteria, ensuring that certain businesses or products may be exempt from the stringent requirements for nutritional labeling.
Let's break down the key concepts from the article you provided:
Small Business Exemptions for Nutritional Labeling:
Exemption Possibility #1:
- Sales Thresholds: Businesses can be exempt if they conduct:
- $500,000 or less in annual gross sales of all products OR
- $50,000 or less in annual gross sales of food products.
- Condition for Exemption: The exempted food products must avoid making any nutrition claims in their product or advertising.
Exemption Possibility #2 - Low Volume Exemption:
- Employee and Sales Volume Thresholds: Businesses with fewer than:
- 100 full-time employees and
- 100,000 units sold in the US in the preceding 12 months may be exempt from certain labeling requirements.
- Condition for Exemption: The labels or product advertising for exempted foods must not provide any nutrition information or make nutrient content or health claims.
Registration of Small Business Labeling Exemption:
- Registration Requirement: If the exempt business is not an importer and sells fewer than 10,000 units annually, there's no mandatory registration for the exemption.
- Registration Procedure: For businesses not meeting the criteria, an annual filing for exemption is necessary, either online or via mail/fax.
Foods Exempt From Labeling Requirements:
- Specific Food Categories Exempt: Various food categories are exempt from labeling requirements, including:
- Raw fruits, vegetables, fish
- Dietary supplements regulated under §101.36
- Certain egg cartons, infant formula, foods for children up to 4 years (with modified requirements)
- Foods with insignificant nutrient amounts (e.g., coffee beans, tea leaves, spices, food colors)
- Packaged single-ingredient FDA-regulated meats (e.g., deer, bison)
- Small packaged foods (<12 sq inches)
- Foods served for immediate consumption or in bulk containers with ingredient listings
- Foods prepared and sold exclusively within a retail establishment
- Ingredients added for processing at insignificant levels
- Products in transit for further processing, packing, or labeling at another facility
Understanding these exemptions is crucial for businesses navigating the complex landscape of food product labeling regulations set by the FDA.
